title: A multicenter phase 2 study of risk-adjusted salvage chemotherapy incorporating vinorelbine and gemcitabine for relapsed and refractory lymphoma.
abstract: BACKGROUND
  Administration of salvage chemotherapy to patients with relapsed or refractory lymphoma is associated with significant toxicity. Vinorelbine and gemcitabine are novel chemotherapeutic agents with minimal overlapping toxicity. We present a phase 2 study of vinorelbine and gemcitabine with or without ifosfamide administered in an ambulatory care setting for relapsed or refractory lymphoma.
  
  
  METHODS
  Ninety patients were enrolled. Group 1 comprised patients with "good" risk disease, Group 2 comprised patients with "high" risk disease, and Group 3 comprised patients relapsing after prior stem cell transplant. Patients in Group 1 and Group 3 received vinorelbine and gemcitabine with filgrastim support (VGF); those in Group 2 received the above regimen with ifosfamide (FGIV). We incorporated a standardized interim evaluation with dose escalation for patients with suboptimal response after 2 cycles.
  
  
  RESULTS
  Toxicities were acceptable. Febrile neutropenia was uncommon: 7% after VGF (7 of 107 cycles) and 19% for FGIV (26 of 148 cycles). Unplanned admissions occurred in 23 of 107 cycles (21%) after VGF and 50 of 148 (34%) after FGIV. Overall response for Groups 1, 2 and 3, respectively was 76%, 39% and 50%, with median overall survival of 28, 9 and 30 months.
  
  
  CONCLUSIONS
  Vinorelbine-based and gemcitabine-based chemotherapy is effective in the salvage setting against lymphoma and can be administered in an ambulatory setting.
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Melbourne, Australia.
authors.forename: Sant-Rayn
authors.initials: SR
authors.lastname: Pasricha
authors.forename: Andrew
authors.initials: A
authors.lastname: Grigg
authors.forename: John
authors.initials: J
authors.lastname: Catalano
authors.forename: Michael
authors.initials: M
authors.lastname: Leahy
authors.forename: Craig
authors.initials: C
authors.lastname: Underhill
authors.forename: Chris
authors.initials: C
authors.lastname: Arthur
authors.forename: James
authors.initials: J
authors.lastname: D'Rozario
authors.forename: Ray
authors.initials: R
authors.lastname: Lowenthal
authors.forename: Kate
authors.initials: K
authors.lastname: Reed
authors.forename: Andrew
authors.initials: A
authors.lastname: Spencer
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012306:Risk; D016879:Salvage Therapy; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine